I'm all in as of a few minutes ago. Here is why: Wanted to wait for an expected dip late next week, and have been planning on being back in for a long time, but the registration and other information in the filings today tell me I am out of time.
In my opinion, allowing that I'm not as sharp as many on this board... I have believed from the beginning that the reasons for the hold are:
1) To see if the trial can continue as confirmatory to 6 months (PFS or OS? I have forgotten).
2) To allow the Germans a look at efficacy and finally make a reimbursement $ amount decision. I don't know if those $ decisions are in stone, or if they get modified as more data comes in, but either way, it means money coming in, and possibly a backlog of $ owed from previous treatments, as I believe Flipper has been saying, and probably many others. That sum up front could be substantial. I know that many of you will have a very good guess as to those details. But I have not been following closely lately.
I believe they will be announcing the German reimbursement decision within 4 (trading) days... probably within 4 days of yesterday, but possibly within 4 days of today. Along with that will come an announcement of either a continue, or an early approval with confirmatory. Based on the details of the wording of the S-3 filing, I think it is a continue.
Some might be able to infer the efficacy from the $ amount decided for reimbursement, if that $ amount becomes public.
If the efficacy is 5 months (OS or PFS?)... then DCVax-L is not as good as many thought. But the company has learned a great deal over the many years in the trial, and not all that they have learned would have been allowed into trial changes. Yet after approval, MD's can make tweaks on there own. At least that is my understanding. They can make minor tweaks to the DCVax-L application, but also to the radiation and chemo. Northwest has developed markers to predict the efficacy. Those markers might be useful as feedback to tell the MD's when radiation or chemo has reached the point of too much of a sort of good thing. Maybe that is before they start... but probably not.
It is a new era. The efficacy will go up from whatever the trial yields. That is a near certainty. And as preliminary genetic testing becomes standard, and other adjuncts get developed, those improvements will continue to grow, until DCVax-l gets replaced altogether with DCVax-Direct. Maybe never for GBM, and only GBM, but probably, eventually, for GBM also.
As long as the income from DCVax-L is substantial compared to combined trial costs, the investment becomes so derisked that the eventuality of DCVax-Direct becomes something to embrace now. Maybe. Sort of. And I'm stickin to it! Maybe, sort of, is as far as I back-peddle.
AI
